Medtronic Warning Letters Lifted, Clearing Path For CRM, Neurostim PMAs
This article was originally published in The Gray Sheet
A barrier to FDA approval for several of Medtronic's core product candidates was lifted with the firm's announcement March 9 that longstanding warning letters had been resolved.
You may also be interested in...
The agency posted a warning letter to Medtronic Aug. 21 citing the firm for multiple quality system deviations, including lapses in its efforts to address a failure risk for the SynchroMed II drug infusion pump.